{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PMC",
      "openfda": {
        "k_number": [
          "K211526",
          "K163484",
          "K170871",
          "DEN150010",
          "K191166",
          "K173032",
          "K252289"
        ],
        "registration_number": [
          "3012146457",
          "3021619527",
          "3008938259",
          "3008888703",
          "3044829899",
          "3012187635",
          "1648700"
        ],
        "fei_number": [
          "3012146457",
          "3021619527",
          "3008938259",
          "3008888703",
          "3044829899",
          "3000204260",
          "3012187635"
        ]
      },
      "review_panel": "SU",
      "medical_specialty": "SU",
      "device_name": "Scalp Cooling System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "General, Plastic Surgery",
      "device_class": "2",
      "definition": "A  scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.",
      "regulation_number": "878.4360",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}